Acceptability and feasibility of Micralax® applicators and of methyl cellulose gel placebo for large-scale clinical trials of vaginal microbicides

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Objective(s)To evaluate the feasibility and acceptability of the Micralax® applicator and of methyl cellulose placebo gel for use in vaginal microbicide clinical trials.DesignA two-centre prospective study following women for 2 months.SettingTwo primary health care clinics in South Africa.Patients, participantsFemale volunteers (n = 28) 18 years or older who were HIV negative and had no clinically detectable genital tract abnormalities or reproductive tract infections.InterventionsParticipants used pre-filled Micralax® applicators to apply methyl cellulose gel every other day, as well as up to 1 h before to every episode of vaginal sex.Main outcome measure(s)Consistency in the weight of gel dispensed per application; side-effects attributed to applicator or gel use; and acceptability of the applicator and of the gel.ResultsOver a 2 month follow-up period the 22 women completing the study reported no adverse events related to gel or applicator use. The Micralax® applicator proved acceptable. The gel was not too messy and did not reduce sexual frequency or pleasure. On average, the applicator dispensed 4.7 ml per use (close to the 4 ml planned).ConclusionsThe Micralax® applicator performs well as a delivery system for potential vaginal microbicides; and methyl cellulose is an appropriate placebo for future microbicide trials.

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